Developing Models that are Fit for Purpose — A Model Qualification Method

Mechanistic physiological (“PhysioPD™”) models are graphical and mathematical representations of biology and therapeutic interventions. Strategic use of PhysioPD models and associated virtual patients and experiments can greatly enrich and reduce risk in the drug development process. Relevant models provide critical information and insights for making go/no go decisions, but positive program impact requires that decision-makers have confidence in the model. The model qualification process is specifically designed to instill confidence in mechanistic physiologic models.
In this webinar, Dr. Friedrich will delineate characteristic features of mechanistic physiological models and show some examples. She will then introduce the Model Qualification Method (MQM), which defines concrete criteria for assessing model quality, building confidence, and ensuring buy-in. The MQM provides a basis for using model-based research to impact program decisions.